Drug · FAERS side-effect profile with label screen
Ammonium side effects: what 238 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Ammonium Chloride (Ammonium Muriaticum)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
238 reports · 96% serious · 159 with death outcome · 19% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Low back pain and constipation
FDA label, Indications and Usage
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Reporting / coding artifact 5Lab value / disease marker 2No label text to screen 33
What the badges mean
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 19 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Appendicitis | 88 | 842.1 712.5–995.3ROR 1,335.5 · χ² 72,418 / p <1e-300 | 705.2 EB05 590.0 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 506.1 · 95% clinician | no trial data cached |
| Ventricular fibrillation | 87 | 693.6 586.1–820.9ROR 1,092.7 · χ² 59,042 / p <1e-300 | 597.2 EB05 499.1 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 412.5 · 95% clinician | no trial data cached |
| Cardiogenic shock | 84 | 521.7 438.9–620.1ROR 805.7 · χ² 42,907 / p <1e-300 | 463.6 EB05 386.2 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 309.9 · 95% clinician | no trial data cached |
| Bacterial infection | 93 | 443.4 378.1–520.0ROR 727.1 · χ² 40,438 / p <1e-300 | 404.3 EB05 339.9 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 304.9 · 97% clinician | no trial data cached |
| Hyperlipidaemia | 60 | 443.2 355.9–552.1ROR 592.3 · χ² 25,917 / p <1e-300 | 386.5 EB05 311.2 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 290.6 · 95% clinician | no trial data cached |
| Incorrect route of product administration | 82 | 432.0 362.3–515.1ROR 658.6 · χ² 34,686 / p <1e-300 | 390.6 EB05 324.6 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious PRR 513.9 · 98% clinician | no trial data cached |
| Neuralgia | 97 | 353.8 303.4–412.6ROR 596.5 · χ² 33,673 / p <1e-300 | 329.4 EB05 278.0 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 313.0 · 97% clinician | no trial data cached |
| Blood test abnormal | 56 | 352.8 280.4–443.9ROR 461.1 · χ² 19,230 / p <1e-300 | 313.7 EB05 250.6 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious PRR 321.9 · 96% clinician | no trial data cached |
| Hypercholesterolaemia | 38 | 351.3 262.3–470.5ROR 417.8 · χ² 12,879 / p <1e-300 | 297.5 EB05 226.2 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 222.5 · 97% clinician | no trial data cached |
| Ulcer | 63 | 349.7 282.8–432.5ROR 475.3 · χ² 21,491 / p <1e-300 | 315.0 EB05 255.0 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 262.9 · 95% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 107 | 339.1 294.5–390.5ROR 615.3 · χ² 35,644 / p <1e-300 | 318.6 EB05 271.0 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 201.9 · 95% clinician | no trial data cached |
| Aspiration | 41 | 334.7 253.2–442.4ROR 404.1 · χ² 13,264 / p <1e-300 | 288.5 EB05 221.7 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 204.9 · 98% clinician | no trial data cached |
| Full blood count abnormal | 37 | 310.2 230.6–417.4ROR 367.2 · χ² 11,064 / p <1e-300 | 266.6 EB05 202.0 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious PRR 245.7 · 97% clinician | no trial data cached |
| Gout | 62 | 305.1 246.2–378.1ROR 412.2 · χ² 18,441 / p <1e-300 | 278.0 EB05 224.6 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 274.9 · 97% clinician | no trial data cached |
| End stage renal disease | 61 | 292.7 235.7–363.6ROR 393.3 · χ² 17,401 / p <1e-300 | 267.3 EB05 215.6 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 174.4 · 95% clinician | no trial data cached |
| Micturition urgency | 36 | 280.6 207.6–379.4ROR 330.5 · χ² 9,727 / p <1e-300 | 243.6 EB05 183.9 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 277.0 · 97% clinician | no trial data cached |
| Ascites | 89 | 267.4 226.7–315.3ROR 426.5 · χ² 23,314 / p <1e-300 | 252.1 EB05 211.2 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 161.7 · 96% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 106 | 166.5 144.4–191.9ROR 299.3 · χ² 17,282 / p <1e-300 | 161.4 EB05 137.2 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 102.0 · 95% clinician | no trial data cached |
| Joint injury | 39 | 161.0 120.8–214.5ROR 192.3 · χ² 6,036 / p <1e-300 | 149.1 EB05 113.8 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 124.7 · 97% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 94 | 159.1 135.9–186.3ROR 262.4 · χ² 14,623 / p <1e-300 | 153.9 EB05 129.5 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 110.9 · 96% clinician | no trial data cached |
| Transaminases increased | 39 | 154.9 116.2–206.5ROR 185.1 · χ² 5,808 / p <1e-300 | 143.9 EB05 109.8 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 98.8 · 95% clinician | no trial data cached |
| Blood cholesterol increased | 76 | 143.8 119.4–173.1ROR 210.8 · χ² 10,641 / p <1e-300 | 138.6 EB05 114.4 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious PRR 130.3 · 97% clinician | no trial data cached |
| Sputum discoloured | 15 | 140.0 85.8–228.6ROR 149.4 · χ² 1,931 / p <1e-300 | 119.0 EB05 76.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 109.5 | no trial data cached |
| Stress | 109 | 133.7 116.4–153.6ROR 245.9 · χ² 14,253 / p <1e-300 | 130.5 EB05 111.2 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 132.5 · 95% clinician | no trial data cached |
| Cardiovascular disorder | 35 | 120.7 88.9–164.0ROR 141.4 · χ² 4,036 / p <1e-300 | 113.2 EB05 85.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 77.6 · 97% clinician | no trial data cached |
| Sleep disorder | 92 | 116.0 98.8–136.1ROR 188.5 · χ² 10,394 / p <1e-300 | 113.2 EB05 95.1 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 113.1 · 96% clinician | no trial data cached |
| Diabetes mellitus | 99 | 114.0 98.1–132.6ROR 194.6 · χ² 11,007 / p <1e-300 | 111.5 EB05 94.3 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 74.0 · 97% clinician | no trial data cached |
| Lower respiratory tract infection | 58 | 112.9 90.2–141.3ROR 149.0 · χ² 6,327 / p <1e-300 | 108.8 EB05 87.3 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 71.4 · 93% clinician | no trial data cached |
| Coronary artery disease | 39 | 112.7 84.6–150.3ROR 134.6 · χ² 4,209 / p <1e-300 | 106.8 EB05 81.5 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 68.5 · 97% clinician | no trial data cached |
| Thrombosis | 97 | 106.0 91.0–123.6ROR 178.3 · χ² 10,015 / p <1e-300 | 103.8 EB05 87.6 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 65.7 · 97% clinician | no trial data cached |
| Iron deficiency anaemia | 11 | 105.6 59.3–188.1ROR 110.7 · χ² 1,037 / p 9e-228 | 89.6 EB05 53.4 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.9 | no trial data cached |
| Swelling | 104 | 98.2 85.0–113.5ROR 173.7 · χ² 9,945 / p <1e-300 | 96.4 EB05 81.8 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 94.3 · 96% clinician | no trial data cached |
| Intentional product misuse | 94 | 95.5 81.5–111.7ROR 157.1 · χ² 8,718 / p <1e-300 | 93.6 EB05 78.8 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 129.6 · 97% clinician | no trial data cached |
| Liver function test increased | 23 | 95.1 64.5–140.3ROR 105.2 · χ² 2,049 / p <1e-300 | 88.3 EB05 61.9 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 88.8 · 96% clinician | no trial data cached |
| Obstructive airways disorder | 12 | 94.8 54.6–164.6ROR 99.8 · χ² 1,021 / p 2e-224 | 82.7 EB05 50.4 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.9 | no trial data cached |
| Dry mouth | 86 | 93.7 79.1–110.9ROR 146.1 · χ² 7,813 / p <1e-300 | 91.7 EB05 76.6 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 111.0 · 97% clinician | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 35 | 91.1 67.1–123.7ROR 106.6 · χ² 3,031 / p <1e-300 | 86.8 EB05 65.3 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.4 · 97% clinician | no trial data cached |
| General physical health deterioration | 116 | 89.0 78.2–101.5ROR 172.8 · χ² 10,056 / p <1e-300 | 87.7 EB05 75.1 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious PRR 62.2 · 96% clinician | no trial data cached |
| Drug intolerance | 95 | 87.0 74.5–101.7ROR 144.2 · χ² 8,024 / p <1e-300 | 85.5 EB05 72.0 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 84.9 · 97% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 93 | 85.9 73.3–100.7ROR 140.4 · χ² 7,748 / p <1e-300 | 84.4 EB05 70.9 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.6 · 97% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| General physical health deterioration | 116 | 89.0 78.2–101.5ROR 172.8 · χ² 10,056 / p <1e-300 | 87.7 EB05 75.1 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious PRR 62.2 · 96% clinician | no trial data cached |
| Somnolence (drowsiness) | 112 | 49.1 42.9–56.2ROR 91.9 · χ² 5,278 / p <1e-300 | 48.7 EB05 41.6 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.4 · 96% clinician | no trial data cached |
| Stress | 109 | 133.7 116.4–153.6ROR 245.9 · χ² 14,253 / p <1e-300 | 130.5 EB05 111.2 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 132.5 · 95% clinician | no trial data cached |
| Sepsis (blood infection) | 108 | 85.3 74.2–98.1ROR 155.4 · χ² 8,957 / p <1e-300 | 84.0 EB05 71.6 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.3 · 95% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 107 | 339.1 294.5–390.5ROR 615.3 · χ² 35,644 / p <1e-300 | 318.6 EB05 271.0 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 201.9 · 95% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 106 | 166.5 144.4–191.9ROR 299.3 · χ² 17,282 / p <1e-300 | 161.4 EB05 137.2 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 102.0 · 95% clinician | no trial data cached |
| Swelling | 104 | 98.2 85.0–113.5ROR 173.7 · χ² 9,945 / p <1e-300 | 96.4 EB05 81.8 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 94.3 · 96% clinician | no trial data cached |
| Diabetes mellitus | 99 | 114.0 98.1–132.6ROR 194.6 · χ² 11,007 / p <1e-300 | 111.5 EB05 94.3 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 74.0 · 97% clinician | no trial data cached |
| Thrombosis | 97 | 106.0 91.0–123.6ROR 178.3 · χ² 10,015 / p <1e-300 | 103.8 EB05 87.6 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 65.7 · 97% clinician | no trial data cached |
| Neuralgia | 97 | 353.8 303.4–412.6ROR 596.5 · χ² 33,673 / p <1e-300 | 329.4 EB05 278.0 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 313.0 · 97% clinician | no trial data cached |
| Drug hypersensitivity | 96 | 43.6 37.3–50.9ROR 72.4 · χ² 3,986 / p <1e-300 | 43.2 EB05 36.4 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 71.8 · 96% clinician | no trial data cached |
| Drug intolerance | 95 | 87.0 74.5–101.7ROR 144.2 · χ² 8,024 / p <1e-300 | 85.5 EB05 72.0 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 84.9 · 97% clinician | no trial data cached |
| Intentional product misuse | 94 | 95.5 81.5–111.7ROR 157.1 · χ² 8,718 / p <1e-300 | 93.6 EB05 78.8 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 129.6 · 97% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 94 | 159.1 135.9–186.3ROR 262.4 · χ² 14,623 / p <1e-300 | 153.9 EB05 129.5 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 110.9 · 96% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 93 | 85.9 73.3–100.7ROR 140.4 · χ² 7,748 / p <1e-300 | 84.4 EB05 70.9 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.6 · 97% clinician | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Ammonium?
In FDA FAERS, the most frequently co-reported reaction terms for Ammonium are somnolence, stress, sepsis, multiple organ dysfunction syndrome, hyponatraemia, swelling. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Ammonium have an FDA boxed warning?
No. The FDA label retrieved for Ammonium has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ammonium causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 687eae27-d686-1a0f-e053-2a91aa0a124a, effective 20231016; matched on
openfda.generic_name.exact:"AMMONIUM CHLORIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 59 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.